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EP2944340A1 - Mécanisme d'activation pour dispositif d'administration de médicament et dispositif d'administration de médicament - Google Patents

Mécanisme d'activation pour dispositif d'administration de médicament et dispositif d'administration de médicament Download PDF

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Publication number
EP2944340A1
EP2944340A1 EP14305685.1A EP14305685A EP2944340A1 EP 2944340 A1 EP2944340 A1 EP 2944340A1 EP 14305685 A EP14305685 A EP 14305685A EP 2944340 A1 EP2944340 A1 EP 2944340A1
Authority
EP
European Patent Office
Prior art keywords
cartridge
delivery device
medicament delivery
injection needle
activating mechanism
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP14305685.1A
Other languages
German (de)
English (en)
Inventor
designation of the inventor has not yet been filed The
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sanofi SA
Original Assignee
Sanofi SA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sanofi SA filed Critical Sanofi SA
Priority to EP14305685.1A priority Critical patent/EP2944340A1/fr
Priority to TW104114694A priority patent/TWI652087B/zh
Priority to EP15722706.7A priority patent/EP3142730B1/fr
Priority to DK15722706.7T priority patent/DK3142730T3/en
Priority to US15/309,717 priority patent/US10518032B2/en
Priority to JP2016567627A priority patent/JP6917712B2/ja
Priority to CN201580036732.9A priority patent/CN106470718B/zh
Priority to PCT/EP2015/060288 priority patent/WO2015173166A1/fr
Publication of EP2944340A1 publication Critical patent/EP2944340A1/fr
Priority to US16/727,609 priority patent/US12076534B2/en
Priority to US18/782,551 priority patent/US20240374826A1/en
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2466—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M5/347—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub rotatable, e.g. bayonet or screw
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2006—Having specific accessories
    • A61M2005/2013—Having specific accessories triggering of discharging means by contact of injector with patient body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2026—Semi-automatic, e.g. user activated piston is assisted by additional source of energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2466—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase
    • A61M2005/247—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase with fixed or steady piercing means, e.g. piercing under movement of ampoule

Definitions

  • the invention relates to an activating mechanism for a medicament delivery device and a medicament delivery device incorporating such an activating mechanism.
  • Pre-filled syringes containing a selected dosage of a medicament for administering the medicament to a patient are known in the art.
  • the pre-filled syringes include a hollow injection needle that is in fluid communication with the medicament stored in the cartridge. Due to a long-term storage of the pre-filled syringes, the injection needle can be clogged by the medicament, in particular by a medicament including monoclonal antibodies. A clogged injection needle may lead to an increased injection time.
  • the object is achieved by an activating mechanism according to claim 1 and by a medicament delivery device according to claim 8.
  • an activating mechanism for a medicament delivery device comprising a hollow injection needle, a cartridge containing a dosage of a medicament, a cartridge carrier comprising at least one resilient arm for holding the cartridge, a removable needle cap for covering the injection needle and a drive element that is adapted to couple with the cartridge.
  • the cartridge is retained in a position spaced apart from the injection needle in a proximal direction by the at least one resilient arm when the medicament delivery device is in an initial position, wherein by removing the needle cap, the cartridge is releasable to be pushed into a distal direction by the drive element with respect to the cartridge carrier.
  • the provided activating mechanism for the medicament delivery device enables a reliable delivery of the medicament into a patient.
  • the injection needle is formed as a double-ended needle.
  • the injection needle gets in contact with the medicament immediately before the medicament will be ejected.
  • a risk for a clogged injection needle by the medicament is minimized compared with the related art, whereby an injection time will not be increased.
  • the injection needle can be clogged by the medicament stored in the cartridge due to a long-time storage, when the injection needle is in contact with the medicament all the time.
  • the injection needle With the provided preassembling of the injection needle coupled to the body and spaced apart from the cartridge, the injection needle will keep sterile and clean until the beginning of an injection process.
  • the activating mechanism starts after the needle cap has been removed and thus is very user-friendly.
  • the initial position of the medicament delivery device is a position in which the medicament delivery device would be presented to the user prior to use, whereby the injection needle is not in fluid communication with the medicament stored in the cartridge.
  • the at least one resilient arm is deformed radially outwards when the cartridge is pushed into the distal direction.
  • an inner diameter of the cartridge carrier is increased so that the cartridge can pass the area of the cartridge carrier including the at least one resilient arm and move towards the injection needle to get in fluid communication with it.
  • the cartridge carrier is made from a resilient material, e. g. a plastic.
  • the drive element is designed as a spring unit that is arranged between a proximal end of the cartridge and a proximal end of the cartridge carrier, wherein the drive element is prestressed in the proximal direction when the medicament delivery device is in the initial position and destressed in the distal direction when the needle cap is removed.
  • the arranged needle cap provides a counterforce against the prestressing force of the drive element. By removing the needle cap, no counterforce acts against the drive element anymore. Thus, the force of the destressing drive element pushes the cartridge into the distal direction.
  • the injection needle is allowed to get in fluid communication with the medicament stored in the cartridge, whereby the injection needle pierces a sealing element that is arranged across an open distal end of the cartridge.
  • the sealing element may be designed as a fluid impermeable membrane that seals the medicament and keeps the medicament remaining in the cartridge.
  • the activating mechanism further comprises a sleeve that is arranged within the outer body and that is movable with respect to the outer body so as to cover or to expose the injection needle.
  • the injection needle is covered by the sleeve when the medicament delivery device is in the initial position, wherein the injection needle is exposed when the medicament delivery device is in an operating position due to a proximal movement of the sleeve with respect to the outer body.
  • the sleeve may be withdrawn after the device is removed from an injection site, e.g., a patient's skin.
  • an injection site e.g., a patient's skin.
  • the activating mechanism comprises a bung that is disposed within the cartridge for proximally limiting the cartridge when the medicament delivery device is in the initial position.
  • the activating mechanism further comprises a piston rod that is adapted to engage the bung for displacing it within the cartridge.
  • the bung seals the cartridge proximally, whereby the displacement of the bung within the cartridge, in particular in the distal direction, is realized by a force of the piston rod.
  • the piston rod may replace the spring unit as the drive element pushing the cartridge in the distal direction after the needle cap has been removed. Therefore, the piston rod may be coupled to a button for an automatic medicament delivery or a manual force will be applied on the piston rod.
  • a medicament delivery device comprising an activating mechanism as it is described before.
  • the drive element is coupled to the cartridge carrier by a bayonet socket that ensures a releasable and reliable connection between the drive element and the cartridge carrier. In addition, this enables an easy assembly of the drive element within the medicament delivery device.
  • the at least one resilient arm is designed as a lug-shaped cut out comprising a first section based on a circumference of the cartridge carrier and protruding radially inwards, and a hook-shaped second section protruding axially in the distal direction, wherein the free hook end of the second section protrudes radially inwards.
  • the resilient arm retains the cartridge in position as long as the needle cap is not removed.
  • the needle cap is arranged within the medicament delivery device in a manner such that an inner surface of a proximal end of the removable needle cap bears against an outer surface of the at least one resilient arm, wherein an outer surface near the proximal end of the removable needle cap bears against an inner surface of the cartridge carrier.
  • a medicament delivery device comprising the activating mechanism as it is described before.
  • the medicament delivery device is suitable for use with a manual needle insertion and a manual medicament delivery as well as for use with an automatic needle insertion and/or an automatic medicament delivery.
  • the medicament delivery device is suitable for use in autoinjectors that are sleeve- or button-triggered, in particular sequence independently button-triggered.
  • a powerpack design has to ensure that the piercing of the injection site will start when a needle safety mechanism is activated.
  • proximal section/end refers to the section/end of the medicament delivery device, or the sections/ends of the components thereof, which under use of the medicament delivery device is located the furthest away from the medicament delivery site of the patient.
  • distal section/end refers to the section/end of the medicament delivery device, or the sections/ends of the components thereof, which under use of the medicament delivery device is located closest to the medicament delivery site of the patient.
  • Figure 1 shows a schematic longitudinal section view of an exemplary embodiment of a medicament delivery device 1 according to the present invention, whereby the medicament delivery device 1 is in an initial position P1. Thereby, the medicament delivery device 1 would be presented to a user prior to use.
  • the medicament delivery device 1 comprises a cartridge 2 forming a cavity that contains a selected dosage of a medicament.
  • the cartridge 2 comprises a cylindrically shaped main body and a neck section on a distal end of the main body, whereby a shoulder 2.1 connects the main body and the neck section.
  • the distal end of the cartridge 2 includes a flange to retain a sealing element 2.2, e. g. a fluid impermeable membrane or foil, which is arranged across the open distal end of the cartridge 2.
  • the sealing element 2.2 seals the medicament distally against environmental influences and ensures that the medicament remains within the cartridge 2.
  • the cartridge 2 is proximally limited by a bung 3 that is disposed within the cartridge 2 on a proximal end when the medicament delivery device 1 is in the initial position P1.
  • the bung 3 is arranged spaced from a piston rod 4, whereby the bung 3 isengageable with the piston rod 4.
  • the piston rod 4 is adapted to displace the bung 3 within the cartridge 2 for ejecting the medicament from the cavity through an injection needle 5 that is arranged spaced from the cartridge 2 along a longitudinal axis L in a distal direction D when the medicament delivery device 1 is in the initial position P1.
  • the injection needle 5 is suitable for intramuscular, subcutaneous, intradermal or transcutaneous injections with corresponding lengths.
  • the cartridge carrier 6 comprises a hollow main body for receiving the cartridge 2.
  • An inner diameter of the cartridge carrier 6 is significantly greater than an outer diameter of the cartridge 2.
  • the cartridge carrier 6 comprises two resilient arms 6.1 that retain the cartridge 2 in position before injection, in particular in the initial position P1 or initial state of the medicament delivery device 1. While the exemplary embodiment depicts only two resilient arms 6.1, those of skill in the art will understand that more than two resilient arms 6.1 may be utilized.
  • the resilient arms 6.1 are designed as lug-shaped cut outs divided in a first section 6.1.1 and a second section 6.1.2.
  • the first section 6.1.1 is based on the circumference of the cartridge carrier 6 and protrudes in a radial inward direction.
  • the second section 6.1.2 follows the first section 6.1.1 in a rectangular angle, thus protruding in the distal direction D.
  • the second section 6.1.2 comprises a hook-shaped free end 6.1.2.1, whereby the hook end 6.1.2.1 protrudes in the radial inward direction.
  • the cartridge carrier 6 is made from a resilient material, e. g. a plastic, to enable a radially outward deforming of the resilient arms 6.1.
  • An internal diameter of the cartridge carrier 6 in the area of the resilient arms 6.1 is smaller than the outer diameter of the cartridge 2.
  • the cartridge 2 is held in the cartridge carrier 6 in a manner that the shoulder 2.1 of the cartridge 2 abuts against the hook ends 6.1.2.1 of the resilient arms 6.1.
  • a movement of the cartridge 2 in the distal direction with respect to the cartridge carrier 6 is prevented by the resilient arms 6.1.
  • a removable needle cap 7 that covers and seals an outer needle section 5.1 of the injection needle 5 and that is arranged in a manner that a proximal end of the removable needle cap 7 bears against an outer surface of the resilient arms 6.1, whereby an outer surface near the proximal end of the removable needle cap 7 bears against an inner surface of the cartridge carrier 6 that is located near a distal end of the cartridge carrier 6.
  • a proximal section of the needle cap 7 is arranged between the resilient arms 6.1 and the inner surface of the cartridge carrier 6 relating to a radial direction.
  • the medicament delivery device 1 comprises a drive element 8 that is arranged between a proximal end of the cartridge 2 and a proximal end of the cartridge carrier 6.
  • the drive element 8 is designed as a coil spring unit 11 that is coupled with its proximal end to the cartridge carrier 6 by a bayonet socket.
  • the spring unit 11 may be coupled to the cartridge carrier 6 by any other suitable connection.
  • a distal end of the spring unit 11 is arranged on the proximal end of the cartridge 2, whereby the spring unit 11 is prestressed in the proximal direction P.
  • the needle cap 7 provides a counterforce against the prestressing of the spring unit 11.
  • the spring unit 11 is released and destresses into the distal direction D.
  • the cartridge 2 is pushed in the distal direction D against the resilient arms 6.1 by the destressed spring unit 11, whereby the resilient arms 6.1 are free to move radially outwards, because the needle cap 7 does not bear against the resilient arms 6.1 anymore.
  • the distal movement of the cartridge 2 enables the injection needle 5 to get in fluid communication with the medicament stored in the cartridge 2.
  • the injection needle 5 comprises the outer needle section 5.1 and an inner needle section 5.2 that is targeted inside the cartridge carrier 6 directed to and distally spaced from the sealing element 2.2 of the cartridge 2, when the medicament delivery device 1 is in the initial position P1.
  • the injection needle 5 is coupled to a substantially elongate and cylindrical outer body 9 by a needle thread 5.3 that provides a luer-lock connection to the outer body 9.
  • the injection needle 5 may be coupled to the outer body 9 by any other suitable connection.
  • the outer body 9 centres the cartridge carrier 6 and a sleeve 10 within the outer body 9.
  • the cartridge carrier 6 is rigidly connected to the outer body 9, wherein the sleeve 10 is slidably coupled to the outer body 9 for allowing relative movement in the distal direction D and/or the proximal direction P so as to cover or to expose the injection needle 5.
  • the axial translation of the sleeve 10 corresponds with an insertion depth of the injection needle 5 at least. In the present application, the axial translation of the sleeve 10 is greater than the insertion depth of the injection needle 5.
  • Figure 2 shows a schematic longitudinal section view of an exemplary embodiment of the medicament delivery device 1 according to the present invention, whereby the medicament delivery device 1 is in an operating position P2. Thereby, the injection needle 5 is in contact with the medicament and the injection needle 5 is still covered by the sleeve 10.
  • the medicament delivery device 1 may be operated according to the following exemplary method.
  • the needle cap 7 is removed from the injection needle 5 by pulling off the needle cap 7 with the help of a removal aid 7.1. At this time, the injection needle 5 is still covered by the sleeve 10 preventing a user from touching and seeing it.
  • the spring unit 11 distresses and pushes the cartridge 2 in the distal direction D against the resilient arms 6.1.
  • the resilient arms 6.1 deform radially outwards into the recesses of the cartridge carrier 6.
  • the cartridge 2 moves in the distal direction D with respect to the cartridge carrier 6 and the sleeve 10 until it abuts against the needle thread 5.3, whereby the needle tip of the inner needle section 5.2 pierces the sealing element 2.2 of the cartridge 2.
  • the injection needle 5 is in fluid communication with the medicament, but still covered by the sleeve 10 as it is shown in figure 2 .
  • the medicament delivery device 1 may be held at the outer body 9 and the sleeve 10 is pushed against an injection site, e.g. a patient's skin. Consequently, the sleeve 10 moves in the proximal direction P with respect to the outer body 9 and the cartridge 2 against a force of a not shown spring, by which the sleeve 10 is supported.
  • the cartridge 2 and the injection needle 5 stay in position relative to the outer body 9 while the sleeve 10 moves in the proximal direction P. Hence, the injection needle 5 is exposed and inserted into the injection site. Once the relative movement of the sleeve 10 stops, the injection needle 5 has reached its insertion depth. By pushing the piston rod 4 in the distal direction D, the bung 3 is displaced within the cartridge 2 and the medicament is ejected through the injection needle 5 into the injection site.
  • the medicament delivery device 1 may be button-triggered.
  • the medicament delivery device 1 may be provided with manual needle insertion and manual medicament delivery.
  • the medicament delivery device 1 could be provided with automatic needle insertion and/or automatic medicament delivery in order to adjust the injection force.
  • the medicament delivery device 1 may be provided as a modular unit that is connectable to an autoinjector device.
  • the modular unit may be provided with a blistering.
  • the needle cap 7 and the cartridge carrier 6 are designed in such a manner that a compartment to the inner needle section 5.2 is sterile sealed against the components of the medicament delivery device 1 near the inner needle section 5.2.
  • an audible feedback when the injection process is completed.
  • the audible feedback may be generated by the spring unit 11 in the form of a clicking or snapping sound. This can be performed by support of the piston rod 4 that lifts and releases the spring unit 11, if a proximal end of the piston rod 4 reaches an end position. Consequently, a clicking sound will occur.
  • FIG 3 and 4 show an alternative embodiment of the medicament delivery device 1, whereby the drive element 8 is realized by the piston rod 4.
  • figure 3 show the medicament delivery device 1 in the initial position P1
  • figure 4 show the medicament delivery device 1 in the operating position P2.
  • the piston rod 4 may be coupled to a button for an automatic medicament delivery or the piston rod 4 will be controlled manually by applying a manual force on the piston rod.
  • the piston rod 4 moves into the distal direction D, the piston rod 4 engages with the bung 3. Moving the piston rod 4 further into the distal direction D causes a distal movement of the cartridge 2, because the force required to move the cartridge 2 in the distal direction D is smaller than the force required to move the bung 3 with respect to the cartridge 2 in the distal direction D.
  • the cartridge 2 When the cartridge 2 is pushed in the distal direction D by the piston rod 4 , the cartridge 2 is held in position only by the cartridge carrier 6. In particular, when the needle cap 7 is removed, the sealing element 2.2 will not be pierced immediately, but only when the piston rod 4 is moved distally. Thus, a so-called wet injection may be avoided. Due to the distal movement of the cartridge 2 against the resilient arms 6.1, the resilient arms 6.1 deform radially outwards into the recesses of the cartridge carrier 6. Thus, the cartridge 2 moves in the distal direction D with respect to the cartridge carrier 6 and the sleeve 10 until it abuts against the needle thread 5.3, whereby the needle tip of the inner needle section 5.2 pierces the sealing element 2.2 of the cartridge 2. Now, the injection needle 5 is in fluid communication with the medicament, but still covered by the sleeve 10 as it is shown in figure 4 .
  • an area of the injection needle 5 maybe sealed against environmental influences according to regulatory requirements for medicament combination products.
  • drug or “medicament”, as used herein, means a pharmaceutical formulation containing at least one pharmaceutically active compound, wherein in one embodiment the pharmaceutically active compound has a molecular weight up to 1500 Da and/or is a peptide, a protein, a polysaccharide, a vaccine, a DNA, a RNA, an enzyme, an antibody or a fragment thereof, a hormone or an oligonucleotide, or a mixture of the above-mentioned pharmaceutically active compound, wherein in a further embodiment the pharmaceutically active compound is useful for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism, acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis, wherein in a further embodiment
  • Insulin analogues are for example Gly(A21), Arg(B31), Arg(B32) human insulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.
  • Insulin derivates are for example B29-N-myristoyl-des(B30) human insulin; B29-N-palmitoyldes(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-Y-glutamyl)-des(B30) human insulin; B29-N-(N-lithocholyl-Y-glutamyl)-des(B30) human insulin; B29-N-( ⁇ -carboxyheptadecanoyl)-des(B30) human insulin and B29-N-( ⁇ -carboxy
  • Exendin-4 for example means Exendin-4(1-39), a peptide of the sequence H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.
  • Exendin-4 derivatives are for example selected from the following list of compounds:
  • Hormones are for example hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists as listed in Rote Liste, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.
  • Gonadotropine Follitropin, Lutropin, Choriongonadotropin, Menotropin
  • Somatropine Somatropin
  • Desmopressin Terlipressin
  • Gonadorelin Triptorelin
  • Leuprorelin Buserelin
  • Nafarelin Goserelin.
  • a polysaccharide is for example a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra low molecular weight heparin or a derivative thereof, or a sulphated, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and/or a pharmaceutically acceptable salt thereof.
  • An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium.
  • Antibodies are globular plasma proteins ( ⁇ 150 kDa) that are also known as immunoglobulins which share a basic structure. As they have sugar chains added to amino acid residues, they are glycoproteins.
  • the basic functional unit of each antibody is an immunoglobulin (Ig) monomer (containing only one Ig unit); secreted antibodies can also be dimeric with two Ig units as with IgA, tetrameric with four Ig units like teleost fish IgM, or pentameric with five Ig units, like mammalian IgM.
  • Ig immunoglobulin
  • the Ig monomer is a "Y"-shaped molecule that consists of four polypeptide chains; two identical heavy chains and two identical light chains connected by disulfide bonds between cysteine residues. Each heavy chain is about 440 amino acids long; each light chain is about 220 amino acids long. Heavy and light chains each contain intrachain disulfide bonds which stabilize their folding. Each chain is composed of structural domains called Ig domains. These domains contain about 70-110 amino acids and are classified into different categories (for example, variable or V, and constant or C) according to their size and function. They have a characteristic immunoglobulin fold in which two ⁇ sheets create a "sandwich" shape, held together by interactions between conserved cysteines and other charged amino acids.
  • Ig heavy chain There are five types of mammalian Ig heavy chain denoted by ⁇ , ⁇ , ⁇ , ⁇ , and ⁇ .
  • the type of heavy chain present defines the isotype of antibody; these chains are found in IgA, IgD, IgE, IgG, and IgM antibodies, respectively.
  • Distinct heavy chains differ in size and composition; ⁇ and ⁇ contain approximately 450 amino acids and ⁇ approximately 500 amino acids, while ⁇ and ⁇ have approximately 550 amino acids.
  • Each heavy chain has two regions, the constant region (C H ) and the variable region (V H ).
  • the constant region is essentially identical in all antibodies of the same isotype, but differs in antibodies of different isotypes.
  • Heavy chains ⁇ , ⁇ and ⁇ have a constant region composed of three tandem Ig domains, and a hinge region for added flexibility; heavy chains ⁇ and ⁇ have a constant region composed of four immunoglobulin domains.
  • the variable region of the heavy chain differs in antibodies produced by different B cells, but is the same for all antibodies produced by a single B cell or B cell clone.
  • the variable region of each heavy chain is approximately 110 amino acids long and is composed of a single Ig domain.
  • a light chain has two successive domains: one constant domain (CL) and one variable domain (VL).
  • CL constant domain
  • VL variable domain
  • the approximate length of a light chain is 211 to 217 amino acids.
  • Each antibody contains two light chains that are always identical; only one type of light chain, ⁇ or ⁇ , is present per antibody in mammals.
  • variable (V) regions are responsible for binding to the antigen, i.e. for its antigen specificity.
  • VL variable light
  • VH variable heavy chain
  • CDRs Complementarity Determining Regions
  • an "antibody fragment” contains at least one antigen binding fragment as defined above, and exhibits essentially the same function and specificity as the complete antibody of which the fragment is derived from.
  • Limited proteolytic digestion with papain cleaves the Ig prototype into three fragments. Two identical amino terminal fragments, each containing one entire L chain and about half an H chain, are the antigen binding fragments (Fab).
  • the Fc contains carbohydrates, complement-binding, and FcR-binding sites.
  • F(ab')2 is divalent for antigen binding.
  • the disulfide bond of F(ab')2 may be cleaved in order to obtain Fab'.
  • the variable regions of the heavy and light chains can be fused together to form a single chain variable fragment (scFv).
  • Pharmaceutically acceptable salts are for example acid addition salts and basic salts.
  • Acid addition salts are e.g. HCl or HBr salts.
  • Basic salts are e.g. salts having a cation selected from alkali or alkaline, e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1)(R2)(R3)(R4), wherein R1 to R4 independently of each other mean: hydrogen, an optionally substituted C1-C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6-C10-aryl group, or an optionally substituted C6-C10-heteroaryl group.
  • solvates are for example hydrates.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
EP14305685.1A 2014-05-12 2014-05-12 Mécanisme d'activation pour dispositif d'administration de médicament et dispositif d'administration de médicament Withdrawn EP2944340A1 (fr)

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EP14305685.1A EP2944340A1 (fr) 2014-05-12 2014-05-12 Mécanisme d'activation pour dispositif d'administration de médicament et dispositif d'administration de médicament
TW104114694A TWI652087B (zh) 2014-05-12 2015-05-08 具有啟動機構之藥物輸送裝置
JP2016567627A JP6917712B2 (ja) 2014-05-12 2015-05-11 起動機構を有する薬剤送達デバイス
DK15722706.7T DK3142730T3 (en) 2014-05-12 2015-05-11 MEDICINAL DISPENSER DEVICE WITH AN ACTIVATION MECHANISM
US15/309,717 US10518032B2 (en) 2014-05-12 2015-05-11 Medicament delivery device having an activating mechanism
EP15722706.7A EP3142730B1 (fr) 2014-05-12 2015-05-11 Mécanisme d'activation pour dispositif d'administration de médicament et dispositif d'administration de médicament
CN201580036732.9A CN106470718B (zh) 2014-05-12 2015-05-11 具有启动机构的药剂输送装置
PCT/EP2015/060288 WO2015173166A1 (fr) 2014-05-12 2015-05-11 Dispositif d'administration de médicament comprenant un mécanisme d'activation
US16/727,609 US12076534B2 (en) 2014-05-12 2019-12-26 Medicament delivery device having an activating mechanism
US18/782,551 US20240374826A1 (en) 2014-05-12 2024-07-24 Medicament delivery device having an activating mechanism

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WO2018091917A1 (fr) * 2016-11-18 2018-05-24 Owen Mumford Limited Dispositifs d'administration de médicament
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WO2020002321A1 (fr) 2018-06-25 2020-01-02 Sanofi Dispositif d'administration de médicament
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EP3592403A1 (fr) 2017-03-06 2020-01-15 Amgen Inc. Dispositif d'administration de médicaments doté d'une fonction de prévention d'activation
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US11931552B2 (en) 2015-06-04 2024-03-19 West Pharma Services Il, Ltd. Cartridge insertion for drug delivery device
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US11801347B2 (en) 2015-11-05 2023-10-31 Sanofi-Aventis Deutschland Gmbh Cartridge carrier assembly
WO2017076925A1 (fr) * 2015-11-05 2017-05-11 Sanofi-Aventis Deutschland Gmbh Ensemble support de cartouche
CN109069748A (zh) * 2015-11-27 2018-12-21 赛诺菲-安万特德国有限公司 具有枢转的针保持器的药物注射装置
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WO2018011256A1 (fr) * 2016-07-14 2018-01-18 Sanofi-Aventis Deutschland Gmbh Dispositif d'administration de médicament à protection d'aiguille et manchon de protection commandés
CN109475699A (zh) * 2016-07-14 2019-03-15 赛诺菲-安万特德国有限公司 具有受控的针护罩和盖套筒的药物输送装置
CN109475699B (zh) * 2016-07-14 2021-11-05 赛诺菲-安万特德国有限公司 具有受控的针护罩和盖套筒的药物输送装置
JP2019520929A (ja) * 2016-07-14 2019-07-25 サノフィ−アベンティス・ドイチュラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング 制御されたニードルシールドおよびカバースリーブを含む薬物送達デバイス
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EP3315153A1 (fr) * 2016-10-25 2018-05-02 Sanofi-Aventis Deutschland GmbH Dispositif d'injection de médicament
JP2019531860A (ja) * 2016-10-25 2019-11-07 サノフィ−アベンティス・ドイチュラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング 薬剤注射デバイス
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CN110225774A (zh) * 2016-11-18 2019-09-10 Om有限公司 药物递送设备
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WO2018091917A1 (fr) * 2016-11-18 2018-05-24 Owen Mumford Limited Dispositifs d'administration de médicament
US11717611B2 (en) 2016-11-18 2023-08-08 Owen Mumford Limited Medicament delivery devices
CN111683703B (zh) * 2017-12-22 2022-11-18 西氏医药包装(以色列)有限公司 适用于不同尺寸的药筒的注射器
CN111683703A (zh) * 2017-12-22 2020-09-18 西氏医药包装(以色列)有限公司 适用于不同尺寸的药筒的注射器
US11857767B2 (en) 2017-12-22 2024-01-02 West Pharma. Services IL, Ltd. Injector usable with different dimension cartridges
US11844936B2 (en) 2018-06-25 2023-12-19 Sanofi Medicament delivery device
WO2020002321A1 (fr) 2018-06-25 2020-01-02 Sanofi Dispositif d'administration de médicament

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DK3142730T3 (en) 2018-10-08
US12076534B2 (en) 2024-09-03
US20240374826A1 (en) 2024-11-14
EP3142730B1 (fr) 2018-06-20
EP3142730A1 (fr) 2017-03-22
US10518032B2 (en) 2019-12-31
WO2015173166A1 (fr) 2015-11-19
CN106470718B (zh) 2019-12-10
JP2017515585A (ja) 2017-06-15
US20170136183A1 (en) 2017-05-18
TWI652087B (zh) 2019-03-01
CN106470718A (zh) 2017-03-01
TW201601785A (zh) 2016-01-16
JP6917712B2 (ja) 2021-08-11

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